UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052492
Receipt number R000059904
Scientific Title An exploratory study of the effectiveness of implementing a home care staff collaboration application.
Date of disclosure of the study information 2023/11/01
Last modified on 2023/10/13 17:10:21

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Basic information

Public title

An exploratory study of the effectiveness of implementing a home care staff collaboration application.

Acronym

An exploratory study of the effectiveness of implementing a home care staff collaboration application.

Scientific Title

An exploratory study of the effectiveness of implementing a home care staff collaboration application.

Scientific Title:Acronym

An exploratory study of the effectiveness of implementing a home care staff collaboration application.

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to introduce this application into the home health care setting and to examine its effects on "relational coordination," "home health care workers' sense of safety," "work engagement," "workplace social capital," "psychological safety," "job crafting," and "job performance."

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reassurance of staff during home care nursing

Key secondary outcomes

Relational Coordination
Work Engagement
Workplace Social Capital
Psychological safety
Job Crafting
Job Performance


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Smartphones with the app downloaded will be distributed to the intervention group and used during the intervention period.

Interventions/Control_2

For the control group, smartphones with the app downloaded will not be distributed and will not be used during the intervention period.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Staff working as nurses, assistant nurses, public health nurses, midwives, physical therapists, occupational therapists, speech therapists, or other professionals.

Key exclusion criteria

Staff who did not give research consent

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Ikeda

Organization

Fukuoka University

Division name

Faculty of Medicine

Zip code

814-0180

Address

7-45-1 Nanakuma, Fukuoka City, Fukuoka Prefecture

TEL

092-801-1011

Email

ikedasatoshi@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Ikeda

Organization

Fukuoka University

Division name

Faculty of Medicine

Zip code

814-0180

Address

7-45-1 Nanakuma, Fukuoka City, Fukuoka Prefecture

TEL

092-801-1011

Homepage URL


Email

ikedasatoshi@fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University

Institute

Department

Personal name

Satoshi Ikeda


Funding Source

Organization

MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuoka University - Medical Ethics Review Board

Address

7-45-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka

Tel

092-801-1011

Email

fumed-ethics@fukuoka-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2023 Year 08 Month 07 Day

Date of IRB

2023 Year 08 Month 07 Day

Anticipated trial start date

2023 Year 11 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 10 Month 13 Day

Last modified on

2023 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059904